FDA to Take Enforcement Action Against Manufs. and Distributors of Unapproved Cyanide Antidotes
The Food and Drug Administration said it intends to take enforcement action against unapproved injectable drug products containing sodium nitrite or sodium thiosulfate labeled for the treatment of cyanide poisoning, as well as against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. The antidotes carry serious risks, and unapproved drug products may lack warnings required in the labeling of approved cyanide antidotes, FDA said.
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Manufacturing or shipping these drug products can result in enforcement action, including seizure, injunction, or other judicial or administrative proceeding, it said. FDA will do so without issuing a warning latter or any further warning to firms marketing these drug products. Any drug products covered by FDA’s notice that a company (including a manufacturer or distributor) began marketing after Sept. 19, 2011, are subject to immediate enforcement action, the agency said. For drug products covered by this notice that a company began marketing in the U.S. on or before Sept. 19, 2011, and that are clearly marked and labeled before Nov. 28, 2012, FDA will conditionally allow a grace period for products manufactured before Feb. 26 or shipped before May 27.
If the unapproved products are packaged in a kit with other unapproved drugs or medical products and labeled for treatment of cyanide poisoning, FDA said it intends to take action against the entire kit based on the unapproved sodium thiosulfate and sodium nitrite components.